Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Boston Scientific recalled 16 units of AMS Artificial Urinary Sphincter Control Pumps due to mislabeled packaging where devices labeled as Pressure Regulating Balloons actually contained Control Pumps.
Baxter is recalling MiniCap Extended Life PD Transfer Sets (Part Number 5C4482) due to reports of the female connector separating from the main body. Approximately 409,464 units are affected worldwide.
Philips is recalling 5,231 Mammotrak Diagnostic Coil 1.5T units nationwide because of a potential patient safety issue during MRI scans. The FDA has classified this as a Class II recall.
Philips recalls 5,231 Mammotrak Interventional Coil 3.0T MRI devices nationwide due to a potential safety issue that could harm patients during scan preparation or imaging.
Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to reports of the female connector separating from the transfer set body. The defect may compromise dialysis treatment safety.
Philips is recalling 5,231 dS Breast 7ch 3.0T breast MRI coils distributed nationwide due to a potential safety issue that may harm patients during scan preparation or scanning. The FDA classified this as Class II.
Medline Industries is recalling 408 surgical kits from Alabama, Georgia, Massachusetts, New Jersey, and Pennsylvania. Some suture packages within the kits contain incorrect needle types and sizes, and incorrect suture diameters and lengths.
Philips is recalling 5,231 ST SENSE Breast Coils nationwide due to a potential safety issue that could harm patients during MRI scanning. Affected units are identified by specific serial numbers.
Defibtech DDP-100 defibrillation pads distributed in Ireland had authorized labels replaced with unauthorized ones, making expired pads appear fresh. Dried hydrogel on expired pads may fail to deliver adequate energy for cardiac resuscitation.
Boston Scientific recalls 52 mislabeled AMS Artificial Urinary Sphincter balloons that may contain a Control Pump instead of the labeled Pressure Regulating Balloon component.
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to an increase in complaints of female connector separation from the transfer set body. Peritoneal dialysis patients should contact their healthcare provider.
Shimadzu laboratory autosamplers are being recalled due to water intrusion from a dehumidifier that can cause electrical short circuits. Affected units are distributed worldwide, including across the United States.
Philips is recalling approximately 5,231 SENSE Breast Coil 3.0T units due to a potential safety hazard that could harm patients during MRI scanning procedures.
Gauthier Biomedical is recalling the TriALTIS TORQUE LIMITER due to an out-of-specification component that may cause the device to produce higher torque output than intended. The recall affects 160 units.
Medline is recalling Shoulder Repair Pack-LF surgical kits (lot 24ABO552) due to incorrect needle type/size and suture diameter/length in some packages. No patient injuries have been reported.
MicroSurgical Technology is recalling MST Duet Reusable Handles for surgical forceps and scissors due to pin detachment risk. Six units distributed in the US; 18 internationally.
Philips dS Breast 16ch 3.0T MRI systems are being recalled due to a potential safety issue that could harm patients during medical scans. The FDA-mandated Class II recall affects 5,231 units distributed nationwide.
Baxter is recalling 22,392 units of MiniCap Extended Life PD Transfer Sets (Part Number 5C4482EJ) due to reports of female connector separation. Affected units were distributed worldwide.
INCIPIO DEVICES is recalling 100 units of Offset Cup Impactor surgical instruments (Lot 24A0087) because the TIG weld does not meet specifications and has fractured. These instruments are used in hip surgery to position acetabular cup implants.
Philips is recalling 5,231 units of the Mammotrak Interventional Coil 1.5T nationwide due to a potential safety issue that may harm patients during MRI preparation or scanning.
The recalled Essenz HLM heart-lung machines (38 units) may experience GUI display failures and sensor deactivation. This can lead to hypoxia and hypoperfusion.
Philips is recalling 5,231 Mammotrak Diagnostic Coil 3.0T units due to a potential safety issue that could harm patients during MRI scan preparation or scanning.
Defibtech DDP-200P pediatric defibrillation pads distributed in Ireland are recalled due to unauthorized labeling that could make expired pads appear current, and hydrogel drying that may reduce electrical effectiveness.
Smiths Medical is recalling PORTEX Tracheal Tube Exchange Guides due to potential fluid ingress during reprocessing and inadequate disinfection per applicable standards.
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to increasing reports of the female connector separating from the main body. The defect affects 62,718 units distributed worldwide.
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